Sanofi Abandons Multiple Mid-Stage Drug Programs
Sanofi is ending a mid-stage program for isatuximab for acute lymphoblastic leukemia, and SAR428926, an anti-LAMP1 ADC for solid tumors. Source: BioSpace
FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly…
Macfarlan Smith Cited for GMP Deficiencies
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Source: Drug…
Health Groups Say Right-to-Try Could Do ‘More Harm than Good’
A group of non-profits and activist organizations, including the American Lung Association, National Health Council and National Organization for Rare Disorders, urged lawmakers in the House of Representatives not to…
FDA Issues Considerations for Submitting Impurity Data as ANDA Approvals Drop in January
The FDA released new information for ANDA applicants on when to submit elemental impurity data, and acknowledged that new guidelines on reporting elemental impurities had slowed approvals in January. Source:…
Ousted Arcturus Founder and CEO Claims He was Improperly Pushed Out by 4 Board Members
Joseph E. Payne was shown the door as CEO of Arcturus last week - a move that Payne is not taking lightly. Source: BioSpace
Cambridge's Enumeral Filed for Bankruptcy, Sells Assets to Bay Area's XOMA
It's the end of the road for Cambridge, MA based Enumeral Biomedical. Source: BioSpace
Another Day, Another Breakthrough Tag for GlaxoSmithKline's Bexsero
Bexsero is the first vaccine in the world to receive the designation twice. Source: BioSpace
Biogen Halts Plans to Develop Tysabri for Stroke After Phase IIb Trial Flop
Natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. Source: BioSpace
On a Roll: FDA Calls Sage's Depression Drug a Breakthrough
This is the second Breakthrough Therapy designation granted to Sage since 2016. Source: BioSpace
- Go to the previous page
- 1
- …
- 174
- 175
- 176
- 177
- 178
- 179
- 180
- …
- 610
- Go to the next page